ClinicalTrialsFinder
RecruitingPhase 3NCT07608432

Efficacy, Safety, and Tolerability of Zeleciment Rostudirsen (DYNE-251) Administered Intravenously Every 4 Weeks in Ambulatory Participants With Duchenne Muscular Dystrophy (FORZETTO)

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy, Safety, and Tolerability of DYNE-251 Administered Intravenously in Ambulatory Male Participants 4 to 18 Years of Age With Duchenne Muscular Dystrophy Amenable to Exon-51 Skipping

Sponsor

Dyne Therapeutics

Enrollment

90 participants

Start Date

Jun 1, 2026

Study Type

INTERVENTIONAL

Conditions

Muscular Dystrophy, DuchenneDMDNeuromuscular Diseases (NMD)Muscular DystrophiesDuchenne Muscular Dystrophy (DMD)Muscular Dystrophy in ChildrenGenetic Disease, X-LinkedGenetic Disease, InbornMuscular Dystrophy (DMD)Muscular Dystrophy, Duchenne TypeMuscular Dystrophy, Duchenne and Becker TypesMuscular Dystrophies (Duchenne, Becker, Myotonic Dystrophy)Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Summary

The purpose of the study is to assess the efficacy, safety, and tolerability of zeleciment rostudirsen (DYNE-251) administered intravenously (IV) every 4 weeks to ambulatory Duchenne muscular dystrophy (DMD) participants, 4 to 18 years of age, with dystrophin mutations amenable to exon 51 skipping.

Eligibility

Sex: MALEMin Age: 4 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Placebo and a drug called Zeleciment Rostudirsen (DYNE-251) for people with congenital, hereditary, and neonatal diseases and abnormalities, dmd, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include men aged 4 Years to 18 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGZeleciment Rostudirsen (DYNE-251)

Administered by IV infusion

DRUGPlacebo

Administered by IV infusion

Locations(1)

Rare Disease Research, LLC

Hillsborough, North Carolina, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07608432

Related Trials

Phase 2 Study of SAT-3247 in Pediatric Ambulatory Patients

NCT0728718921 locations

Recruitment and Apheresis Collection of Peripheral Blood Hematopoietic Stem Cells, Mononuclear Cells and Granulocytes

NCT000014051 location

A Phase 3 Study to Evaluate the Safety and Efficacy of AOC 1044 (Also Referred to as Delpacibart Zotadirsen) in Participants With DMD With Gene Mutations Amenable to Exon 44 Skipping

NCT07587242

Clinical Investigation to Validate the Safety and Performance of the ABLE Kids Device in Pediatric Patients With Neurological Gait Disorders in a Clinical Setting

NCT07745712

Interfacing With NeuroTechnology to Expand Neural Throughput (INTENT)

NCT075219301 location